UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038793 |
|---|---|
| Receipt number | R000044227 |
| Scientific Title | Saccadic eye movement speed of an orbital floor fracture |
| Date of disclosure of the study information | 2019/12/05 |
| Last modified on | 2022/12/19 14:53:02 |
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Basic information
Public title
Saccadic eye movement speed of an orbital floor fracture
Acronym
Saccadic eye movement speed of an orbital floor fracture
Scientific Title
Saccadic eye movement speed of an orbital floor fracture
Scientific Title:Acronym
Saccadic eye movement speed of an orbital floor fracture
Region
| Japan |
Condition
Condition
blowout fracture
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of ocular movement disorder in patients with blow out fracture (BOF) have been conducted using HESS red-green screen test (HESS). Though HESS tracks a fixed point slowly and evaluates the deviation, it does not capture the actual movement. We focused on eye movements, specifically saccadic eye movements, and analyzed ocular movement disorder in patients with BOF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
saccadic eye movementsin patients with blowout fracture.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 7 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were patients with an blowout fracture who visited the Showa University Hospital East Branch from July 2016 to July 2017. The study was conducted with the approval of the Showa University Ethics Committee.
Key exclusion criteria
Saccadic eye movement speed measurement date exceeding 30 days from the day of injury, surgery, oculocardiac reflex, white-eyed blowout fracture, and early enophthalmos-/hypoglobus-induced facial asymmetry.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | kota |
| Middle name | |
| Last name | yokoyama |
Organization
Showa University School of Medicine
Division name
Department of Ophthalmology
Zip code
142-8555
Address
1-5-8 hatanodai Shinagawa-ku, Tokyo
TEL
03-3784-8000
k-yokoyama@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | kota |
| Middle name | |
| Last name | yokoyama |
Organization
Showa University School of Medicine
Division name
Department of Ophthalmology
Zip code
142-8555
Address
1-5-8 hatanodai Shinagawa-ku, Tokyo
TEL
03-3784-8000
Homepage URL
k-yokoyama@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Showa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Ethics Committee
Address
1-5-8 hatanodai Shinagawa-ku, Tokyo
Tel
03-3784-8129
gakuji@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
昭和大学病院附属東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000044227
Publication of results
Unpublished
Result
URL related to results and publications
.
Number of participants that the trial has enrolled
67
Results
.
Results date posted
| 2021 | Year | 06 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
.
Participant flow
.
Adverse events
.
Outcome measures
.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Quantitative measurement of the saccadic eye movement speed in normal people(40 people 80 eyes) and patients with BOF(27 patients 27 eyes) used a visual stimulus preparation device (ViSaGe MK 2) combined with an eye tracking device (ViewPoint Eye Tracker).
Management information
Registered date
| 2019 | Year | 12 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044227
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/12/19 | 研究実施計画書（ブローアウト）.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
